NCT01104480

Brief Summary

This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

April 13, 2010

Last Update Submit

May 12, 2014

Conditions

Relapsing Polychondritis

Keywords

Relapsing PolychondritisUnremittingInflammationIL6

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Tocilizumab

    Inhibition of inflammatory markers Improvement in symptoms and signs

    2 years

Secondary Outcomes (1)

  • Safety of Tocilizumab

    2 years

Interventions

TocilizumabDRUG

Tocilizumab 8mg/kg every 2 weeks given by IV infusion

Also known as: Actemra

Eligibility Criteria

Age12 Years - 15 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A single patient with unremitting inflammatory relapsing polychondritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3YZ, Canada

Location

MeSH Terms

Conditions

Polychondritis, RelapsingInflammation

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maggie Larché, MD, PhD

    McMaster University and Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2010

Study Completion

May 1, 2012

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

CA(1)